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Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients
Citation
Sundaran, S and Udayan, A and Hareendranath, K and Eliyas, B and Ganesan, B and Hassan, A and Subash, R and Palakkal, V and Salahudeen, MS, Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients, Pharmacy, 6, (4) Article 108. ISSN 2226-4787 (2018) [Refereed Article]
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Copyright Statement
Copyright 2018 The Authors Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/
DOI: doi:10.3390/pharmacy6040108
Abstract
Hospital-based adverse drug reaction (ADR) monitoring and reporting programs intend
to identify and quantify the risks associated with the use of medicines. To examine the causality,
preventability and severity of ADR in a hospital setting; a prospective cohort study on spontaneous
ADR reporting was conducted from December 2015 to May 2016. Incidence of ADRs, causality, type,
severity and preventability were assessed using necessary assessment scales. The study included
3157 hospitalized individuals, in whom 51 ADRs were detected among 49 patients. The overall
incidence of suspected ADRs was found to be 1.6%. According to the causality assessment, most of
the ADRs reported were probable (n = 26, 51.0%), and type A (augmented/pharmacological) reactions
(n = 39, 76%) were the most common type of ADR found. The majority of ADRs were moderate
to severe (n = 35, 68.6%), of which 37.3% were found to be potentially preventable. Predictability
was observed in 28 (54.9%) reported ADRs. The prescribed medicines most frequently associated
with ADRs were antibiotics, antiepileptics and antihypertensives. This feasibility study was able to
highlight the clinical pharmacist’s role in ADR monitoring service and create awareness about the
way it could be done to promote safer medication use. Similar ADR reporting programs are necessary
to educate and to improve awareness among healthcare professionals in some countries.
Item Details
| Item Type: | Refereed Article |
|---|---|
| Keywords: | adverse drug reactions, spontaneous reporting, causality, ADR, severity |
| Research Division: | Biomedical and Clinical Sciences |
| Research Group: | Pharmacology and pharmaceutical sciences |
| Research Field: | Clinical pharmacy and pharmacy practice |
| Objective Division: | Health |
| Objective Group: | Public health (excl. specific population health) |
| Objective Field: | Health status (incl. wellbeing) |
| UTAS Author: | Salahudeen, MS (Dr Mohammed Salahudeen) |
| ID Code: | 129178 |
| Year Published: | 2018 |
| Web of Science® Times Cited: | 17 |
| Deposited By: | Pharmacy |
| Deposited On: | 2018-11-13 |
| Last Modified: | 2019-02-22 |
| Downloads: | 77 View Download Statistics |
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